MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

Patient Problems Pain (1994); Obstruction/Occlusion (2422)

Event Date 02/27/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

The procedure was a stent removal- ureter when the physician went to remove the stent, he noticed it was encrusted, and that a small wire from the stent was sticking into patient urter.Nothing was left in the patient.Extensive time to remove, patient was reported to come back for observation due to pain management.The patient did not experience adverse effects due to this occurrence patient outcome: the patient did not experience adverse effects due to this occurrence patient/event info - notes : 2.0 rpn prefix: stpv-083070-rms rms dpsci 2.1 general questions for all complaints: 2.1.1 are any images available for review? yes- see attachments 2.1.2 what was the target location for the stent? stent was in the ureter-- this was a removal procedure 2.1.3 did anything have to be removed from the patient? yes ¿ if yes, please specify: ¿ (i) what part of the body the device was removed from? ureter ¿ (ii) what device was removed? the stent and a piece of the stent was sticking into the ureter ¿ (iii) what instrument was used to remove it? 2.1.4 please specify the storage conditions of the device at the facility, particularly those relating to light and temperature 2.1.5 why was the stent removed? n/a, exchange, other ¿ if other, please detail why the stent was removed 2.1.6 if the stent was removed what was used to complete the procedure? 2.1.7 what was the length of the indwell time? 2.1.8 what disease mode was the physician trying to treat? 2.1.9 what type and size wire guide was used with the device? 2.1.10 did the device come with a pigtail straightener? n/a, yes, no ¿ if yes, was the pigtail straightener used? n/a, yes, no 2.1.11 did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a, before, after 2.1.12 did the user attempt to attach the tapered end of the stent to the inserter? n/a, yes, no 2.1.13 was this device assembled outside of the body? n/a, yes, no 2.1.14 did the patient require any additional procedures as a result of this event? yes, extensive time to remove, patient was reported to come back for observation due to pain management.2.1.15 what intervention (if any) was required? 2.1.16 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 2.1.17 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no ¿ if yes, please specify what was observed and where on the device it was observed.

• Brand Name: RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19123910
• MDR Text Key: 341461510
• Report Number: 3001845648-2024-00182
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1